Needle assembly having a folded bandage handle

ABSTRACT

A needle assembly including a needle having a pointed end, the needle being removably secured to a flexible air breathable bandage which is folded, the needle extending from one corner thereof in the cross-folded form. The needle is provided with a flexible connecting tube and a connector for attachment to a user device. The flexible bandage forms a manipulable winged handle in the initial folded form, and serves to enable the insertion of the needle into a patient&#39;&#39;s body, after which the bandage is unfolded and is adhered to the skin of the patient&#39;&#39;s body, preferably by adhesion of a pressure sensitive adhesive surface on one face of the bandage. In the unfolded form the bandage covers the puncture site, and after needle use the needle may be removed while leaving the bandage in place, leaving the puncture site covered by the bandage.

United States Patent 1191 Baldwin 1 1 NEEDLE ASSEMBLY HAVING A FOLDEDBANDAGE HANDLE [75] Inventor: Brian E. Baldwin, Wilmette, I11.

[73] Assignee: Affiliated Hospital Products, Inc., St.

Louis, Mo.

[22] Filed: Oct. 17, 1972 [21] Appl. No.: 298,282

Related U.S. Application Data [63] Continuation of Ser. No. 42,713, June2, 1970,

abandoned.

[52] U.S. Cl 128/214 R; 128/155; 128/D1G. 26

3,589,361 6/1971 Loper et a1. 128/2144 111 3,885,560 [451 May 27, 19753,630,195 12/1971 Santomieri 128/133 Primary Examiner-Richard A. GaudetAssislam Examiner-.l. C. McGowan Attorney, Agent, or Firm-Reginald F.Pippin, Jr.

1 1 ABSTRACT A needle assembly including a needle having a pointed end,the needle being removably secured to a flexible air breathable bandagewhich is folded, the needle extending from one corner thereof in thecross-folded form. The needle is provided with a flexible connectingtube and a connector for attachment to a user device. The flexiblebandage forms a manipulable winged handle in the initial folded form,and serves to enable the insertion of the needle into a patients body,after which the bandage is unfolded and is adhered to the skin of thepatients body, preferably by adhesion of a pressure sensitive adhesivesurface on one face of the bandage. 1n the unfolded form the bandagecovers the puncture site, and after needle use the needle may be removedwhile leaving the bandage in place, leaving the puncture site covered bythe bandage.

35 Claims, 22 Drawing Figures mm m 2 7 m5 SHEET FIG.

FIG. 2

BRIAN E. BALDWIN INVENTOR PATENTED W2 7 1975 SHEETI!lllllrllllllllilllllllll llllll1l-lllIIllIIlll1ll1lll FIG. 3

BRIAN E. BALDWIN V INVE NTOR ATTORNEY $55751 H1112? B a SHEET 3 BRIAN E.BALDWIN ATTORNEY SHEET 4 FIG. 5

BRIAN E. BALDWIN INVENTOR ATTORNEY SHEET BRIAN E. BALDWIN INVENTORPATENTEH Ll, j;

SHEET 6 BRIAN E. BALDWIN INVENTOR ATTORNEY SHEET 7 FIG. l0

BRIAN E. BALDWIN ATTORNEY PATENTED W27 B SHEET 8 FIG. I l

BRIAN E. BALDWlN INVENTOR ATTORNEY FATEHTEB IILYZ 7 I875 SHEET FIG. I2

W W D L A B E N m R B ATTORNEY R O T N v m PATENTED W 27 m5 SHEET FIG.I3

BRIAN E. BALDWIN INVENTOR ATTORNEY 0 PO :J IQ m0 HTEPHES 5 SHEET FIG. l4

ATTORNEY mamas m 2 Y i m a a. a 5

SHEET 1 2 FIG. l5

BRIAN E BALDWIN INVENTOR ATTORNEY SFLEET 1 3 PSA ; 515 any? mam;

BRIAN E. BALDWIN INVENTOR ATTORNEY PAIENIEOIIAYZ? ms on I SHEET 14 FIG.I8

BRIAN E. BALDWIN INVENTOR ATTORNEY FL P M a SHEET FIG. l9

BRIAN E. BALDWIN SHEET FIG. 20

BRIAN E. BALDWIN INVENTOR ATTORNEY BR|AN E. BALDWiN INVENTOR ATTORNEYPATE HEB MY 2 7 [975 SHEET FIG. 22

BRIAN Ev BALDWIN INVENTOR ATTORNEY NEEDLE ASSEMBLY HAVING A FOLDEDBANDAGE HANDLE This is a continuation, of application Ser. No. 42,713filed June 2, 1970, now abandoned.

This invention relates to an attachable needle assembly for removableattachment to a body member, and more particularly to a manuallymanipulable needle assembly for insertion into and attachment to apatients body, such as for intravenous therapy or testing (using ahollow needle and fluid connection thereto), or for electrical signal.

In the art of intravenous therapy it is necessary to insert a needleinto the vein of a patient, and to retain the needle in place for anextended period of time, the time varying with the particularintravenous therapy or testing involved. It has been previously proposedand practiced to insert such intravenous needles manually into the vein,as by holding the needle or needle holder and puncturing the body, afterwhich a strip of adhesive may be applied to the needle to hold such inplace. This method requires the operator to have ready a strip ofadhesive. and to thereupon apply the adhesive while holding the needlein place. While such is to some degree satisfactory, it has been founddesirable to provide better methods and arrangements for needleinsertion and attachment to the body.

One such prior arrangement is shown in US. Pat. No. 3,064,648, whichincludes a needle with a semi-flexible plastic wing section permanentlyconnected to the needle and having weakened portions which enable theplastic wing sections to be elastically folded to form a manual handle.This device readily enables the manual insertion of the needle. Thesubsequent securing of the needle to the patients body is accomplishedby the employment of a strip of adhesive tape which appears to be placeddirectly over the down-folded wings to cover the wings and adhere to aportion of the body adjacent the wings. This device does have theadvantage of providing a handle for the hand of the operator, but has anumber of distinct disadvantages, including the requirement for theadditional securing tape to be added thereto to secure the needleassembly to the patients body. In addition, this needle assemblyprovides no self-contained portion for covering the puncture site, andthis leaves it to the operator to decide whether to cover this site,although such in fact is desirable as an aid to prevention ofcontamination. The device also tends to prevent skin breathing in thezone over which the down-folded wings lie, as the wings are formed ofsolid or continuous plastic material. There are also distinct pressurepoints or zones at the edge junction of the wings with the securesurface, and this edge junction also forms a bacteria collection pointinasmuch as the skin is depressed along this zone by the tape-down ofthe plastic wings to the patients skin. The device also requires theremoval or release of the adhesive tape securing strip and the removalof the entire attachable needlc assembly, including the needle andplastic wings, in order to remove the needle from the patient.

It is an object and feature of the present invention to provide anattachable needle assembly which enables an operator to manuallymanipulate, insert and secure the needle in place without touching theneedle, and which incorporates a multi-use bandage which serves both asa manually manipulable handle for needle insertion and as a needlesecuring bandage and sitecovering bandage after insertion of the needle.

It is still a further object and feature of the invention to provide amanually manipulable needle and bandage assembly which enables the readymanual insertion of the needle, the self-contained securing of theneedle to the body and the covering of the puncture site by the bandagewhich initially enables manual manipulation and insertion of the needle.

It is a further object and feature of the invention to provide amanually manipulablc wing-forming selfadhering bandage and needleassembly which enables covering of the needle puncture site andsubsequent removal of the needle without removal of the bandage from itscovering of the needle puncture site, whereby the bandage can be left inplace and continue to provide effective cover for the puncture site.

It is an additional object and feature of the invention to provide aneedle and bandage assembly, in which the bandage serves as a manualhandle in a folded form thereof, and subsequently serves as aself-contained needle securing means in unfolded condition, and in whichthe bandage has a pressure sensitive adhesive thereon for ease ofself-adhering attachment to a pa tient's body, the bandage being formedof air breathable material for patient comfort and minimization of skinirritation.

Still a further feature of the invention is the provision of a combinedneedle and bandage arrangement which enables the bandage to be adheredto a body to hold the needle in place after puncture of the body by theneedle with the aid of the bandage as a manual handle, and which enablesthe needle to be easily removed from the puncture site without requiringthe bandage to be removed, either simultaneously or prior to the removalof the needle, thereby materially reducing the likelihood of vein damagewhich might otherwise result from bandage arrangements where removal ofthe needle requires removal of the adhered bandage.

Still other objects, features and attendant advantages will becomeapparent to one skilled in the art from a reading of the followingdetailed description of a pre ferred embodiment constructed inaccordance with the invention, taken in conjunction with theaccompanying drawings wherein:

FIG. 1 is a perspective view of one physical embodiment constructed inaccordance with the invention.

FIG. 2 is a view similar to that of FIG. 1, illustrating the device inan upsidedown position for clarity of illustration of certain parts.

FIG. 3 is a fragmentary longitudinal section view of FIG. 1 with a coversheath added.

FIG. 4 is a partially exploded view of the unfolded arrangement of FIG.1.

FIGS. 5 and 9-13 illustrate steps in the insertion and securing of theneedle assembly to a patients arm.

FIGS. 6-8 illustrate optional pre-insertion manipulative steps.

FIGS. 14 and IS illustrate steps in removal of the needle from thepatients arm while leaving the bandage in place.

FIGS. 16 and 17 are perspective views of a modification of thearrangement of FIG. 1.

FIGS. I8-20 illustrate steps in the securing of the modified arrangementof FIGS. 16 and [7 to a patients arm.

FIG. 21 is a perspective view of a further embodiment according to theinvention.

1. An attachable needle assembly for removable attachment to a bodymember of a human or animal, comprising a needle having a pointed endfor insertion into a body member, a flexible bandage including amultipurpose flexible securing sheet having a pressure-sensitiveadhesive securing surface adapted to adhere to the skin surface of aneedle-penetrable body, said bandage, including its said securing sheet,being cross-folded to form a folded winged handle for said needle, withfour fold-interconnected sections, and means securing said needle tosaid flexible bandage-securing sheet along a fold of said sheet, saidneedle extending beyond said winged handle, said securing sheetfold-interconnected sections each having an adhesive securing surfacewith removable protective backing thereon, the adhesive securing surfacebacking of two of said sections facing outwardly away from one another,and the adhesive securing surface backing of two other of said sectionsfacing inwardly toward one another in the cross-folded condition, andbeing internal sections of said winged handle, said two sections of saidwinged handle facing outwardly away from one another being externalsections, and their respective removable protective backing formingmanual engagement and gripping surfaces.
 2. An attachable needleassembly according to claim 1, said winged handle comprising two wingsfolded about two lines transverse to one another, one of said linesextending substantially longitudinally of the lengthwise extent of saidhollow needle and the other of said lines extending substantiallytransversely of the length of said needle.
 3. An attachable needleassembly according to claim 2, said fold lines intersectingsubstantially in the zone of a portion of said needle.
 4. An attachableneedle assembly according to claim 3, said fold lines including twoadjacent folded layers of said bandage having similar extending foldlines extending longitudinally of said needle and having a fold linetransverse to both of said similarly extending fold lines and having areverse bend in a zone of intersection with said similarly extendinglines.
 5. An attachable needle assembly according to claim 2, saidremovable protective backing comprising a removable protective coversheet over the pressure-sensitive adhesive securing surfaces of saidwings surfaces to enable grasping and handling of said wings as handlesfor insertion of said needle, and to prevent bandage sectioninter-surface self-adherence between interfacing section surfaces.
 6. Anattachable needle assembly according to claim 5, said removableprotective cover sheets being more stiff than said flexible securingsheet to provide a stiff handle while enabling relative ease ofconformity of the securing sheet to a patient''s body, and to enableease of removal of said cover sheets prior to or during adhesivesecuring of said securing sheet to a body.
 7. An attachable needleassembly according to claim 2, said removable protective backingcomprising removable protective cover sheets over the pressure-sensitiveadhesive securing surfaces of said wings to enable grasping and handlingof said wings as handles for insertion of said needle.
 8. An attachaBleneedle assembly according to claim 1, said needle being connected to aflexible connecting tube at its end opposite said pointed end, saidneedle being secured to said bandage by an overlay strip encompassing asection of said flexible tube and secured to a surface of said bandage.9. An attachable needle assembly according to claim 8, said overlaystrip encompassing the zone of connection of said needle with saidflexible tube.
 10. An attachable needle assembly according to claim 9,said overlay strip being secured to said flexible securing sheet on itssurface opposite to said pressure-sensitive surface.
 11. An attachableneedle assembly according to claim 10, said overlay strip being a taperemovable from said flexible securing sheet without destruction of saidflexible securing sheet.
 12. An attachable needle assembly according toclaim 8, said overlay strip being secured to the surface of saidflexible securing sheet opposite to said pressure sensitive adhesivesecuring surface, said needle extending through an opening formed in acentral zone of said flexible securing sheet, said central zone openingbeing formed at a fold corner of said folded bandage.
 13. An attachableneedle assembly according to claim 1, said needle extending through anopening formed in a central zone of said bandage in unfolded form andlying at a fold corner of said cross-folded bandage.
 14. An attachableneedle assembly according to claim 1, said bandage having transversequadrant-forming folds forming said folded winged handle, said needleextending from a fold corner of said bandage and extending substantiallylongitudinal of one of said folds.
 15. An attachable needle assemblyaccording to claim 14, said needle being secured to a face of saidbandage.
 16. An attachable needle assembly according to claim 15, saidneedle being secured to a face of said bandage opposite saidpressure-sensitive adhesive securing surface, and said needle extendingthrough an opening formed at said fold corner of said bandage.
 17. Anattachable needle assembly according to claim 15, and a cover stripsecuring said needle to said pressure sensitive adhesive securingsurface of said bandages.
 18. An attachable needle assembly according toclaim 14, said transverse folds forming two double-fold wings.
 19. Anattachable needle assembly according to claim 18, said double-fold wingshaving a common fold line zone longitudinal of said needle.
 20. Anattachable needle assembly according to claim 18, said double fold wingshaving a common fold line zone transverse to said needle.
 21. Anattachable needle assembly according to claim 1, said needle beinghollow, a hollow tube secured to said needle at a central zone of theunfolded form of said bandage, and means for securing said tube to afluid-use device.
 22. An attachable needle assembly according to claim1, said needle forming an electrode for transmission of electricalsignals to or from a body into which it may be inserted.
 23. A portableand manually manipulable needle and bandage assembly unit for insertionin and adhering connection to a body member as a unit, comprising afolded flexible securing sheet forming a manually graspable handle inits folded form and having intersecting cross-fold lines formed by afirst fold along one line and a second fold along a line transverse toand intersecting said first fold forming at least fourfold-interconnected sections, a pointed needle secured to said sheet andextending through an opening formed in a central zone of said sheet atthe intersection of said fold lines and beyond its folded periphery,said securing sheet having an adhesive surface on one face thereof and aremovable protective backing thereon, said needle being removablysecured to said foldable flexible securing sheet on the face thereofopposite said adhesive surfaced face.
 24. A Needle and bandage assemblyaccording to claim 23, said removable protective backing comprisingplural protective cover backing sheets removably adhered to saidadhesive surfaced face of said flexible securing sheet, said protectivecover backing sheets extending to and along and adjacent at least one ofsaid fold lines.
 25. An assembly according to claim 23, said flexiblesecuring sheet being of air-breathing form.
 26. An assembly according toclaim 23, and a removable securing strip removably securing said needleto said flexible securing sheet, said flexible securing sheet with itssaid adhesive surface and said removable securing strip being airbreathable to enable breathing of a body surface onto which suchsecuring sheet may be attached.
 27. An attachable freely manuallymanipulable and portable needle assembly unit for removable attachmentto a body, comprising a needle having a pointed end, a multifunctionflexible bandage secured to said needle, said flexible bandage includinga flexible body-surfaceconformable cover sheet cross-folded transverselyof and in the general direction of the longitudinal extent of saidneedle to form at least four fold-interconnected sections to enable easeof insertion of said needle into a body, and for unfolded covering of apuncture site formed upon insertion of said needle into a body member,as well as for aid in securing of said needle to said body said needleextending beyond said cross-folded sheet.
 28. An attachable needleassembly according to claim 27, said bandage having two wings foldedabout two lines transverse to and intersecting one another, one of saidlines extending substantially longitudinally of and adjoining thelengthwise extent of said hollow needle and the other of said linesextending substantially transversely of and intersecting the effectivelengthwise extent of said needle.
 29. An attachable needle assemblyaccording to claim 27, said bandage including two adjacentfold-interconnecting panels each having fold lines extendinglongitudinally of said needle, and having a further fold line transverseto both of said longitudinally extending fold lines, said further foldline having a rearward bend in a zone of intersection with saidlongitudinally extending lines.
 30. An attachable needle assemblyaccording to claim 27, said flexible bandage cover sheet having asurface with pressure-sensitive adhesive material thereon, andreleasable protective sheets covering a major portion of saidpressure-sensitive adhesive material and being readily releasablyadhesively secured thereto.
 31. An attachable needle assembly accordingto claim 30, said flexible bandage cover sheet being formed of airbreathable porous material.
 32. An attachable needle assembly accordingto claim 27, said needle extending from a corner folded portion of saidbandage while said bandage is in the cross-folded form.
 33. Anattachable needle assembly according to claim 32, said corner being theintersecting corner for two cross-folds of said bandage.
 34. Anattachable needle assembly according to claim 30, said releasableprotective sheets being relatively stiffer than said bandage cover sheetto provide a combined stiff manual handle and a separated relativelymore flexible and conformable said bandage cover sheet.
 35. Anattachable needle assembly for removable attachment to a body member ofa human or animal, comprising a needle having a pointed end forinsertion into a body member, a flexible bandage including amultipurpose flexible securing sheet having a pressure-sensitiveadhesive surface adapted to adhere to the skin surface of aneedle-penetrable body, and means securing said needle to said flexiblebandage securing sheet, said bandage, including its said securing sheet,being cross-folded in at least four panels to form a folded wingedhandle for said needle, said securing sheet folded panels each having anadhesive securing surface with removable protective backing thereon, theadhesive surface backing of two of said folded panels facing outwardlyaway from one another, and the adhesive backing surface of two other ofsaid folded panels facing inwardly toward one another in thecross-folded condition, said needle adjoining a fold zone of saidbandage in the folded condition of said bandage.